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Completed Phase 1Phase 2 Interventional Results available

RAD001 and Intravesical Gemcitabine in BCG-Refractory Primary or Secondary Carcinoma In Situ of the Bladder

ClinicalTrials.gov ID: NCT01259063

Public ClinicalTrials.gov record NCT01259063. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 5:50 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Phase I/II Study of RAD001 and Intravesical Gemcitabine in BCG-Refractory Primary or Secondary Carcinoma In Situ of the Bladder

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to test the safety of gemcitabine applied to the bladder directly combined with different oral doses of everolimus and to assess the right doses. Gemcitabine will be given at a fixed dose. Up to 3 dose levels of everolimus will be evaluated. The purpose of the phase II part is to test the combination of gemcitabine applied to the bladder directly combined with different oral doses of everolimus and to study the effects of these two drugs together. The investigators want to find out what effects, good and/or bad, this treatment has on the patient and the cancer.

Study identification

NCT ID
NCT01259063
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Enrollment
33 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 30, 2010
Primary completion
May 31, 2017
Completion
May 31, 2017
Last update posted
Mar 12, 2018

2010 – 2017

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Memorial Sloan Kettering Cancer Center New York New York 10065

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01259063, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 12, 2018 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01259063 live on ClinicalTrials.gov.

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